A Comparison of Revision Surgery after Implant-Based Breast Reconstruction Between Smooth, Textured and Polyurethane-Covered Implants: Results from the Dutch Breast Implant Registry
- Conditions
- Implant-based breast reconstruction after mastectomy
- Registration Number
- DRKS00033421
- Lead Sponsor
- Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Centre Rotterdam, Rotterdam, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 4000
Inclusion Criteria
All permanent breast implants inserted for immediate direct-to-implant or two-stage IBBR after therapeutic or prophylactic mastectomy from September 2017 to November 2022
Exclusion Criteria
Delayed reconstructions, reconstructions involving additional surgical techniques (fat grafting, autologous flaps, mastopexy), reconstructions that were preceded by any previous breast implant surgery (excluding TE insertion as part of a two-stage reconstruction), or non-silicone-filled implants
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was surface-related revision surgery defined as reoperation after insertion of the permanent implant during which the implant was repositioned, replaced or explanted for an indication that might have been the result from the implant surface, i.e., asymmetry, Breast Implant-Associated Illness (BII), breast pain, capsular contracture, deep wound infection, device malposition, device rupture, newly diagnosed breast cancer, seroma or hematoma, suspicion of or pathology-confirmed BIA-ALCL, silicone extravasation or a recall. In the Netherlands, it is mandatory to register all revisions of a breast implant in the Dutch Breast Implant Registry and therefore all data necessary for this study is available in there.
- Secondary Outcome Measures
Name Time Method Subgroup analyses will focus on revision surgery due to capsular contracture, asymmetry, malposition, and breast pain.